Description

Phenacetin Impurity 22 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for the quality control and regulatory compliance of pharmaceutical products, specifically those related to phenacetin. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling to ensure drug safety and efficacy.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of impurities in phenacetin and related drug substances.
• Analytical Method Development: Used as a standard to develop and validate HPLC, GC, or LC-MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Essential for in-process testing and final release testing of active pharmaceutical ingredients (APIs) to meet pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed to monitor the formation of degradation products in drug formulations under various storage conditions.
• Regulatory Compliance & Documentation: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization.
• Research & Development: Used in academic and industrial R&D to study the metabolism, synthesis pathways, and chemical behavior of phenacetin-related compounds.

Basic Information

Product Name	Phenacetin Impurity 22
CAS No.	24176-83-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-(4-Ethoxyphenyl)-2-methylpropan-2-amine; 4'-Ethoxy-2-methylpropan-2-yl-aniline; Phenacetin Related Compound; Phenacetin Impurity B; Phenacetin EP Impurity B; Acetophenetidin Impurity; N-(4-Ethoxyphenyl)-2-methylpropan-2-amine
EINECS	Contact for details

Quality Control

Every batch of Phenacetin Impurity 22 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Comprehensive Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Keep the container tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.